Tagged with USA

USA The FDA’s Sarah Yim discusses the evolving regulatory landscape for biosimilars in the US, the shift toward analytical-heavy reviews over large clinical studies, the legislative push to simplify interchangeability, and the agency’s commitment to increasing market competition and patient access through streamlined development pathways. My goal, and the FDA goal…

USA Philip Macnabb serves as Chief Executive Officer of Curia, bringing 25 years of private equity-backed healthcare experience to his first venture into the CDMO sector. Joining in March 2023, Macnabb leads a globally diversified CDMO with 20 facilities spanning drug discovery through commercial manufacturing, serving predominantly biotech customers whilst maintaining…

USA David Barrett has led the American Society of Gene & Cell Therapy (ASGCT) since 2018, guiding its evolution into the leading professional body for scientists, clinicians, industry leaders and patient advocates in cell and gene therapy. Founded in 1996, ASGCT now sits at the centre of research, education and policy…

USA Matt Heck, founder and CEO of Sentynl Therapeutics, outlines the company’s acquisition-led rare disease strategy following its integration into Zydus Group in 2017. He discusses building a focused portfolio of life-extending paediatric therapies, leveraging orphan drug incentives, prioritising early diagnosis, expanding internationally, and partnering closely with patient foundations to maximise…

USA Jeff Allen is the President & CEO of Friends of Cancer Research, a research policy and advocacy organisation based in Washington, DC. His organisation works to accelerate the development of cancer therapies through evidence-based policy and collaborative research partnerships. Allen highlights the importance of diagnostics and biomarker testing to help…

USA Patients and carers with lived experience of a disease have valuable insights to share with physicians and drug developers alike. This is especially true of rare diseases, defined in the US as those that affect fewer than 200,000 people nationwide and which collectively impact over 30 million Americans. For these…

USA Tony Zook reflects on how decades in pharmaceutical leadership inform his perspective on diagnostics as the backbone of precision oncology. This discussion traces NeoGenomics’ evolution from a haematology specialist to a broader oncology platform spanning therapy selection, next-generation sequencing (NGS), and molecular residual disease (MRD). Set against the realities of…

USA Dr Anthony Letai reflects on how a career spanning cancer biology, clinical oncology, and translational research is shaping his early priorities as Director of the National Cancer Institute. The conversation examines how NCI is navigating a shifting global research landscape while accelerating innovation, strengthening evidence-based decision-making, and reinforcing confidence across…

USA Chris Peetz, co-founder and CEO of Mirum Pharmaceuticals, reflects on the company’s journey from rescuing overlooked rare disease programs to building a growing global pharmaceutical company. He discusses Mirum’s expanding commercial portfolio, pipeline momentum, and disciplined acquisition strategy, while emphasizing the importance of patient-centered execution in rare disease. Peetz also…

USA Precision medicine increasingly depends on diagnostics that can keep pace with therapeutic innovation while remaining accessible in real-world care. Jonathan Arnold reflects on how QIAGEN approaches oncology and emerging hereditary disease programmes by aligning diagnostic development with pharmaceutical pipelines, prioritising decentralisation, and investing in technologies that support both translational insight…

USA John Murphy III, President and CEO of the Association for Accessible Medicines (AAM), argues that 2026 represents a pivotal moment for the United States to reclaim leadership in biosimilars. He outlines how recent FDA reforms could finally unlock competition, lower drug costs, and expand patient access, while warning that outdated…

USA As rare disease science accelerates, regulators face growing pressure to adapt without compromising rigour. In this interview, Amy Comstock Rick explains how the FDA Rare Disease Innovation Hub is strengthening cross-centre coordination, evolving evidence expectations for ultra-rare conditions, and creating new spaces for dialogue between regulators, developers, and patients. The…